Please note: The primary source of all information regarding PAR-22-058: Emergency Awards: HEAL Initiative: Translational Science Career Enhancement Awards for Early and Mid-career Investigators (K18 Clinical Trials Not Allowed) is the funding opportunity itself and any notices linked therein.
Translational science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.
NCATS has defined seven characteristics that distinguish translational scientists — being a systems thinker, a skilled communicator, a rigorous researcher, a domain expert, a process innovator, a team player and a boundary crosser
A potential translational science career-enhancement experience would provide the awardee with varied translational research opportunities over the course of the grant period. The areas of requisite capabilities and expertise are described in the funding opportunity announcement (FOA). The entire translational process for a single project or program may be difficult to see because translation can be a rather lengthy process. Thus, the awardee may participate in several projects and programs at various stages of the translation process to gain the full breadth of the experience.
Yes. These funding opportunities were issued in response to the declared public health emergency issued by the Secretary of Health and Human Services. This public health emergency exists nationwide as the result of the opioid crisis; therefore, projects must focus on addressing pain and/or OUD.
The K18 grant supports a research career development program for early- to mid-career investigators. This funding mechanism provides support to experienced scientists who wish to broaden their scientific capabilities or make changes in their research careers by acquiring new research skills or knowledge.
A sound research project that is consistent with the candidate’s level of research development and objectives of their career development plan must be provided. A detailed description of required content for the research is described in the FOA. It is important to note that the application should provide a detailed description of environments that will ensure a broad translational research experience.
Responsive applicants will have identified a host institution prior to application to the funding opportunity. The candidate must name a primary mentor who, together with the candidate, is responsible for planning, directing, monitoring and executing the proposed program at the translational science site. The application must include a statement from the mentor providing the following: (1) information on their research qualifications and previous experience as a research supervisor and (2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period.
A short-term period is considered to be up to 12 months.
Responsive applications to this funding opportunity do not require an IRB. These applications will have identified a host institution that provides an opportunity to view many aspects of the translational process. Any requirement for an IRB should be addressed by the translational science center.
No. No clinical trial component to this opportunity is required. Applications proposing an independent clinical trial, a clinical trial feasibility study or an ancillary study to a clinical trial will be considered nonresponsive to this funding opportunity. However, if the applicant is proposing to gain experience in a clinical trial, an ancillary study to a clinical trial, or a clinical trial feasibility study on which the mentor or co-mentor is the Principal Investigator as part of his or her research career development, he or she must describe the relationship of the proposed research project to the clinical trial.
The following will be considered nonresponsive and will not be reviewed:
- Applications that propose that the K scholar lead an independent clinical trial, a trial feasibility study or an ancillary study to a clinical trial
- Applications that propose experiences that are not associated with the development of therapies for pain, addiction or overdose
NIH will provide salary and fringe benefits for the award recipient. The guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094. The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap.
No. This funding opportunity does not require specific milestones. This FOA is a short-term career-enhancement opportunity aimed at providing the applicant with a broad educational experience in the translational research environment. Project milestones are not expected for career-enhancement experiences.
This funding opportunity is designed for early- and mid-career scientists with pain or opioid abuse expertise who are interested in receiving hands-on experience in translation at an industry laboratory or an academic or government research center performing therapeutic development activities.
For the purposes of this FOA, the following definitions apply:
- An early-career investigator is a new investigator or an individual at the level of an assistant professor who has completed the terminal research degree or medical residency — whichever date is later — within the past 10 years and has not yet competed successfully for a substantial, competing NIH research grant.
- A mid-career investigator is at the level of an associate professor or functioning at that rank in an academic setting or an equivalent nonacademic setting with an established record of independent, peer-reviewed, patient-oriented research grant funding and a record of publications at the time of application.